Mesoblast Submits New Information to FDA IND File in Response to CRL

 Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the substantial new information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA, represents a major milestone in the Company’s complete response to the FDA. Remestemcel-L has been granted Fast Track Designation and BLA Priority Review from the FDA.

Survival outcomes have not improved over the past two decades for children or adults with the most severe forms of SR-aGVHD.^1-3 The lack of any approved treatments for children under 12 means that there is an urgent need for a therapy that improves the dismal survival outcomes in children.

https://www.biospace.com/article/releases/mesoblast-submits-new-information-to-fda-ind-file-in-response-to-items-in-the-crl-to-the-remestemcel-l-bla-for-sr-agvhd/